Outsourced Pharma, Contract Pharmaceutical, CRO, CMO, Pharmaceutical Drug Development Services

FEATURED EDITORIAL

AI Stuck Upstream? It Still Influences Manufacturing Outsourcing

AI may help run and optimize bioreactors at your CDMO. There is pervasive pressure to move manual (and reactive) control to AI-autonomous (predictive systems). You may already select your CDMO partially based on its systematic utilization of AI in its facilities. But at this moment of transition, while the odds are high AI may not fully reside in the manufacturing plant today, it increasingly shapes the decisions determining what and how programs get to that plant.

GUEST COLUMNISTS

Why Contamination Control By Design Should Matter To Your CDMO
EU GMP Annex 1 mandates a documented contamination control strategy, and FDA expectations are substantively equivalent. Let's look at why CDMOs are disproportionately exposed.
Closing The MES Value Gap: Why Technology Isn't The Problem
Manufacturing execution system (MES) technical maturity is rising, but adoption across manufacturing sites is uneven. Organizational readiness may hold the key.
Why Isolators Do Not Automatically Ensure Annex 1 Compliance
Isolators are powerful tools, but they do not automatically ensure compliance with EU GMP Annex 1. RABS are frequently dismissed too quickly. The difference is not the technology itself, but how it is applied.
Why Are Life Science Companies So Poorly Prepared For RIM's Future?
Most organizations have modernized their global regulatory information management (RIM) systems and improved data quality. Yet modernization and readiness are not the same thing.
CDMO Capacity Crunch: Are Biotechs Wasting Time On The Wrong CDMO?
Biotechs often default to one of two flawed instincts: pursue the biggest name in the space or go with the lowest bidder. To avoid misalignment, look at these less visible factors.
April 2026 — CDMO Opportunities And Threats Report
Each month, Outsourced Pharma works in conjunction with PharmSource, part of GlobalData, to present its “Contract Manufacturing: Opportunities and Threats (CMOT) Report” to our readers. The report identifies CDMOs that might be impacted by key events affecting their clients, including company acquisitions, product acquisitions and licenses, product approvals, late clinical product terminations, and FDA rejections.
Tackling The Cell & Gene Therapy Sector's Practical Post-Approval Problem
As the regulatory landscape continues to evolve, cell and gene therapy companies must plan post-approval change programs with regulatory monitoring built in from the start.
Why Your MES RFP Is Failing Before It Starts
Many manufacturing execution system requests for proposals fail. Not because vendors cannot deliver or the tech is immature, but because the requirements are written backward.

PHARMA OUTSOURCING WHITE PAPERS

Quality By Design Understanding And Securing Virus Clearance
Data-driven virus clearance improves risk assessment, process insight, and study design. Learn how Quality by Design cuts late-stage risk while strengthening regulatory confidence and viral safety.

Modern Lentiviral Platforms For Scalable Cell Therapy
A new platform approach streamlines lentiviral vector design and manufacturing, boosting yield, lowering costs, and accelerating access to gene‑modified cell therapies worldwide.
Digital Innovation And Sustainability Are Redefining Biomanufacturing
Next Generation Manufacturing (NGM) integrates advanced process design, digital innovation, and strategic facility planning to facilitate agile, efficient, and sustainable biopharmaceutical production.
Navigating CMC Regulation For Plasmid DNA In Gene Therapy
Explore how evolving regulatory pathways and CMC innovation are shaping the future of gene therapy and viral vector production, plus what to consider when selecting a CDMO partner.
Overload Setting – Tricks And Techniques
Learn how a partner company that is committed to assisting manufacturers with calibration and optimal set-point establishment can serve as a valuable resource in achieving optimal tablet production.
Molecular Properties Of PROTACs And The Relationship To Formulation Design
Here, we conduct a comprehensive analysis of diverse PROTAC (Proteolysis Targeting Chimeras) structures, evaluating their calculated physicochemical properties to identify key trends.